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About
This is a Phase II clinical trial assessing the safety, tolerability, and pharmacokinetics of LTC004 in combination with MIL-97 ± chemotherapy in patients with advanced or metastatic pancreatic cancer.
This experiment is divided into two parts: the dose increasing stage (stage 1) and the dose expanding stage (stage 2). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
19.Patients who received other investigational drugs or treatments not yet approved within 4 weeks before the first dose.
20.Subjects who have received live attenuated vaccines or live vaccines within 4 weeks before the first dose, or are expected to receive live attenuated vaccines or live vaccines during the study period; 21.Individuals who underwent major surgery within 4 weeks before the first dose (excluding diagnostic procedures), are expected to undergo major surgery during the study period (excluding diagnostic procedures), or have had diagnostic or minimally invasive surgery within 7 days before the first dose (excluding puncture biopsies); 22. Patients whose adverse reactions from previous anticancer therapy have not recovered to Grade 1 according to CTCAE 5.0 (except for Grade 2 alopecia and Grade 2 neuropathy caused by chemotherapy, Grade 2 hypothyroidism induced by anticancer therapy, and Grade 2 reduction in hemoglobin); 23.Individuals who have previously undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 24.Pregnant or lactating women; 25.Subjects judged by the investigator to have a history of other serious systemic diseases or any other reasons (such as mental illness, alcoholism, substance abuse, or drug abuse) that may affect trial compliance and make them unsuitable for participation in this study
Primary purpose
Allocation
Interventional model
Masking
26 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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